Using laser therapy to treat oral mucositis in children with leukemia

Effectiveness of Laser Therapy of Different Wavelengths in Chemotherapy Induced Oral Mucositis in Children With Acute Lymphoblastic Leukemia

This study is testing whether two different types of laser therapy can help reduce mouth sores in children with leukemia who are getting chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 3 Years to 14 Years
• Sex: All
• Sponsor: Children's Cancer Hospital Egypt 57357 (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Cairo and 1 other locations)
• Trial ID: NCT05452668 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of two different wavelengths of laser therapy in managing oral mucositis, a common complication in children undergoing chemotherapy for acute lymphoblastic leukemia. The study involves a randomized, prospective, double-blind design, where participants aged 3 to 14 years with grade 2 or more oral mucositis will be assigned to receive either a 660 nm or 970 nm laser treatment, or a sham treatment without laser emission. Patients will be monitored for pain levels and the severity of oral mucositis over a period of 11 days, following standard hospital care protocols.

Who should consider this trial

Good fit: Ideal candidates are children aged 3 to 14 years with acute lymphoblastic leukemia who are currently in the induction phase of chemotherapy and have developed oral mucositis grade 2 or higher.

Not a fit: Patients receiving radiotherapy or those with unstable clinical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the severity of oral mucositis and improve the quality of life for children undergoing chemotherapy.

How similar studies have performed: Previous studies have shown promising results with laser therapy for oral mucositis, suggesting potential efficacy in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Patients with Acute Lymphoblastic Leukemia in the induction therapy phase and have oral mucositis grade 2 or more.
2. Age: 3-14 years old of both genders.
3. No previous treatment with laser.
4. Ability to open mouth for more than 2 cm for the duration of laser application with a level of cooperation (Frankl rating 3 or 4).
5. Patients who still have 10 days in their induction therapy phase or can be followed up for a mininum of 10 days after the development of oral mucositis

Exclusion Criteria:

1. Patients receiving radiotherapy
2. Received oral Cryotherapy or IV keratinocyte growth factor for oral mucositis
3. Patients with unstable clinical condition (e.g. sepsis)
4. Patients who will be withdrawn from participation according to their request or due to loss in follow up

Where this trial is running

Cairo and 1 other locations

• Children Cancer Hospital Egypt 57357 — Cairo, Egypt (Recruiting)
• Children Cancer Hospital in Egypt 57357 — Cairo, Egypt (Recruiting)

Study contacts

• Principal investigator: Hussein ElNoury, MSc — NewGiza University
• Study coordinator: Ebtesam Hanafy

Conditions Oral Mucositis; Childhood Acute Lymphoblastic Leukemia; Laser therapy; low level laser therapy